(114 days)
The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional Combined Spinal Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for insertion into the spinal and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the cather tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
Pajunk's EpiSpin set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a Combined Spinal-Epidural (CSE) anesthesia kit consisting of two needles, one for insertion into the epidural space (a specialized Tuohy Cannula) and one for insertion into the spinal space (a Sprotte Cannula). This needle through-needle technology is accomplished using an aperture in the curved tip of the specialized Tuohy Cannula (called the "backeye"), for advancement of the Sprotte Cannula into the spinal space. The Spinal needle does not bend at all, but passes easily thru the Tuohy needle. There is no significant friction of metal against metal involved at all.
The provided document is a 510(k) Premarket Notification Submission for the EpiSpin Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive independent clinical study data with acceptance criteria and performance metrics typically seen for novel devices.
Therefore, the document does not contain specific acceptance criteria, comprehensive study results proving device performance against those criteria, or the detailed information on study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that you requested.
The document primarily focuses on:
- Device Description: What the EpiSpin set is and its components.
- Predicate Devices: Identifying previously cleared devices to which the EpiSpin kit claims substantial equivalence.
- Sterilization: Details about the sterilization process.
- Technological Characteristics: How the device works (needle-through-needle technology).
- Indications for Use: The intended applications for the EpiSpin kit and its individual components (LOR-Syringe, Fixolong, Flat Filter, Tuohy Borst Adaptor, Anesthesia conducting Catheter).
- Substantial Equivalence Conclusion: A statement that the device is safe, effective, and substantially equivalent to the predicate devices.
- FDA Clearance Letter: Confirmation of FDA's substantial equivalence determination.
Key Missing Information for your request:
- Acceptance Criteria Table and Reported Device Performance: This document does not present specific quantitative acceptance criteria or detailed performance data against them. The "proof" of meeting criteria is typically the claim of substantial equivalence to existing devices that have already met such criteria.
- Sample sizes for test set and data provenance: No dedicated clinical studies with test sets are described. The equivalence is based on design and material similarity and performance comparison to predicate devices, not on new clinical trials with specified sample sizes.
- Number and qualifications of experts for ground truth: No such experts are mentioned for a new study.
- Adjudication method: Not applicable as no new test set is described.
- MRMC comparative effectiveness study: No such study is mentioned or provided.
- Standalone algorithm performance: This is a physical medical device, not an AI algorithm, so standalone performance in that context is not relevant.
- Type of ground truth used: No new ground truth is established for efficacy in this submission; the basis is substantial equivalence to legally marketed devices.
- Sample size for training set and how ground truth was established for training set: These concepts are not applicable to the type of premarket notification presented for this physical medical device.
In summary, the provided document does not contain the detailed study information you are requesting because it is a 510(k) submission focused on demonstrating substantial equivalence, not on presenting novel clinical trial data with specific acceptance criteria and performance metrics.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).